Sentinel Lymph Node BiopsySLNcxcaNCT03680833
Sentinel Node Detection in Cervical Cancer
A study testing Sentinel node detection in cervical cancer in people with Sentinel Lymph Node Biopsy, run by Region Skane at 1 site in Sweden.
Trial summary
Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Sentinel Lymph Node Biopsy
- What is being tested?
- Sentinel node detection in cervical cancer
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jun 2014to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women of age 18 years and older at the time of informed consent.
- Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery
- Absence of any exclusion criteria
Who cannot join
- Non consenting patients
- Ongoing pregnancy
- Inability to understand written and/or oral study information
- Who performance status III or more
- Previous lower limb lymphedema
- Surgical contraindication to a laparoscopic approach or lymphadenectomy at surgeons discretion.
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- Anesthesiologic contraindication to a laparoscopic approach at the anesthetist's discretion
- Locally advanced disease or intraabdominal/distant metastases at preoperative CT, MRI or ultrasonography
- Radiologically suspect pelvic nodal metastatic disease according to the RECIST criteria (>= 1 node with >=16 mm short axis diameter)
- Allergy to Iodine
- Patients with a known liver disease
- Patients with a significant bleeding disorder or mandatory antithrombotic treatment.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Gynecology and Obstetrics
Lund, 22185
Jan Persson, ass professor, +46733522080, jan.persson@med.lu.se
Linnea Ekdahl, MD, +46739292631, linnea.ekdahl@med.lu.se
About this study
Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer
Read the detailed description
Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.
Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.
Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.
An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.
As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.
- Conditions
- Sentinel Lymph Node Biopsy
- Being tested
- Sentinel node detection in cervical cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel node detection in cervical cancerProcedure or surgery
The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes
| Study group | Role | What they receive |
|---|---|---|
| prospective cohort study | Other | Prospective cohort study with detection of sentinel lymph nodes followed by a full pelvic lymphadenectomy. Patients will act as their own controls.
The intervention is the detection and removal of sentinel lymph nodes Receives: Procedure: Sentinel node detection in cervical cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol
Detection of Sentinel nodes followed by full pelvic lymphadenectomy
Measured: 4-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start15 Jun 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph Node BiopsyStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective cohort study
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Persson, ass professor, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680833
- Sponsor's protocol ID
- RegionSkaneKKLund2
- Acronym
- SLNcxca
- Status last verified
- Sep 2018
- First submitted
- 14 Sep 2018
- Last updated
- 26 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Node Detection in Cervical Cancer
- ClinicalTrials.gov ID
- NCT03680833
- Acronym / sponsor ID
- SLNcxca / RegionSkaneKKLund2
- Conditions
- Sentinel Lymph Node Biopsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 15 Jun 2014 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer
Detailed description
Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria.
Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers.
Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated.
An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients.
As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| prospective cohort study | Other | Procedure: Sentinel node detection in cervical cancerProspective cohort study with detection of sentinel lymph nodes followed by a full pelvic lymphadenectomy. Patients will act as their own controls. The intervention is the detection and removal of sentinel lymph nodes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women of age 18 years and older at the time of informed consent.
- Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery
- Absence of any exclusion criteria
Key exclusion criteria (12 listed)
- Non consenting patients
- Ongoing pregnancy
- Inability to understand written and/or oral study information
- Who performance status III or more
- Previous lower limb lymphedema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel node detection in cervical cancerThe study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes | Procedure or surgery | prospective cohort study |
Primary outcome
Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol
Time frame: 4-5 years
Detection of Sentinel nodes followed by full pelvic lymphadenectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Persson, ass professor principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel node detection in cervical cancer in people with Sentinel Lymph Node Biopsy, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan Persson, ass professor (+46733522080, jan.persson@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol (time frame: 4-5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2018.